Edge Pharma Phenylephrine HCl Syringes Recalled for Sterility Assurance
Edge Pharma, LLC is recalling Phenylephrine HCl 0.5 mg/5mL single-use syringes for intravenous injection nationwide due to lack of assurance of sterility. The affected product was distributed between September 2021 and January 2022.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug product. Loss of sterility assurance in an intravenous medication poses significant risk of serious injury or infection, meeting the threshold for Severe classification even though no hospitalizations or illnesses are explicitly reported in the source text.
Plain-English summary
Edge Pharma, LLC is recalling 3,747 syringes of Phenylephrine HCl 0.5 mg/5mL (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, NDC 05446-1545-05, manufactured at their facility in Colchester, Vermont.
The recall was issued because the manufacturer cannot assure the sterility of the product. Phenylephrine HCl is an injectable medication that must meet strict sterility standards for safe intravenous use.
The affected product was distributed nationwide with lot codes 09-2021-09@4 (expiration 12/22/2021) and 10-2021-14@1 (expiration 01/26/2022). Healthcare providers and patients who have this product should stop using it and contact their healthcare provider for guidance.
Consumers or healthcare professionals with questions or who believe they have been harmed should contact Edge Pharma, LLC or report the issue to the FDA.
The recalled product
- Product
- Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
- Manufacturer
- Edge Pharma, LLC
- Hazard
- sterility-assurance
- injectable-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 09-2021-09@4 12/22/2021 & 10-2021-14@1 01/26/2022
Distribution
Distributed nationwide across the United States.
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